Pharmaceutical closure



Jan. 5, 1954 R. B. PUTZ PHARMACEUTICAL CLOSURE Filed Jan. 15, 1951 INVENTOR.

Z M M Patented Jan. 5, 1954 PHARMACEUTICAL CLOSURE Rodney B. Putz, Burbank, Calif., assignor to Don Baxter, Inc., Glendale, Calif., a corporation of Nevada Application January 15, 1951, Serial No. 206,013

Claims.

This invention relates to a pharmaceutical closure of the type employed on vacuum containers for intravenous solutions.

The general object of the present invention is to provide a simpler form of closure for vacuum containers which reduces the number of parts required in such a closure and. at the same time facilitates the operation of opening the container.

Another object of the present invention is to provide a form of closure which will be tamperproof providing an improvement in the protection of the container against contamination.

The closure of the present invention consists essentially of a stopper or rubber plug which is to be fitted into the neck of a container of an intravenous solution. This stopper may be either of the open hole type or the closed hole type. In the case of the open hole type only the closure comprises a gum rubber disc resting on the top of the stopper and covering the holes of the stopper and held to the stopper by the vacuum within the container. The closure of the present invention includes as additional elements only a single meta1 cap and a sheet of metal foil having a plastic film laminated thereto. The metal cap includes a clamping ring which engages the neck of the container and includes a top section which extends over the upper end of the plug and serves to retain the plug within the container and also to provide an annular seal for the closure. Preferably the foil extends underneath the rim of the cap and is clamped by the cap-to the plug. The cap is also provided with a removable center section which serves to provide a location for an embossed identification. This removable center section is designed to serve as a knife when removed from the remainder of the cap, which knife is intended for cutting the foil seal. The removable center section is also preferably stiffened with an embossed ring which provides an additional sealing ring,

By means of the present invention there is provided a tamper-proof closure which is capable of maintaining the appearance and sterility of the solution under all conditions of processing, shipping and storing. The closure may be readily opened when desired without the employment of any additional instruments or tools. It provides a permanent identification visible to the user before and while the container is being opened.

Various further advantages of the closure of the present invention will be apparent from the following description of the preferred forms of the invention. The description is given in con- 2 nection with the accompanying drawings, in which:

Figure 1 is a plan view of the closure which includes the open hole type of stopper;

Figure 2 is a section on substantially the line 2-2 of Figure 1;

Figure 3 is a plan view of the form of the clo sure employed using the closed hole stopper; and

Figure 4 is a section on the line -44 of Figure 3.

Referring to the drawings, 2 indicates the neck of a container, such as a glass bottle, which is intended to hold an intravenous solution, the neck being provided with one or more beads 3 as indicated. At the neck of the bottle there is provided a plug or stopper 4 which comprises a cylindrical portion extending into the neck 2 and preferably a flange 5 which extends over the rim of the neck 2. The flange 5 provides a means for restraining the plug 4 from being drawn within the container by a vacuum within the container. As usual such plug 4 is provided with a number of openings, such as indicated at 6 and 7 for the removal of the contents of the solution and for the entrance of air, and in one of said openings there is indicated a glass tube 8. V

In order to seal the holes 6 and l in theplug or stopper when a vacuum is drawn in the container and to provide a hermetic seal over the holes there is provided a disc 9 of flexible material, such as gum rubber.

The closure also includes a diaphragm of metal foil l0, which is rendered moisture-proof by a film of plastic laminated thereto. The film of plastic may be of the order of .0005 of an inch in thickness and can be of various plastic materials, such as vinyl, acetate, cellophane, Pliofilm, tetrachlorofiuoroethylene, polyethylene, etc. The purpose of the film of plastic material is to fill any pinholes in the metal diaphragm and, moreover, to give support to the metal diaphragm or foil so that it will out evenly. This diaphragm or metal foil It extends over preferably the entire upper surface of the stopper 4 enclosing completely the rubber disc 9 and preferably having its edge turned down over the rim of the stopper, as indicated at 19. The foil provides a moistureproof and dust-proof barrier to the container, which barrier may be readily removed when it is desired to utilize the contents.

The closure also includes 'a metal cap I l, which metal cap may be formed of aluminum, or other satisfactory metal, which cap is intended to assist in retaining the stopper in the bottle; For this purpose the metal cap is indicated as including the ring l2 which clamps against the neck of the bottle, preferably around one of the beads 3.

The center section of the cap includes the annular ring [3 and the removable center section 14. The annular ring I3 is pressed against the foil diaphragm l forcing the same against the flange 5 of the stopper providing at this point an annular seal as Well as serving to provide means for retaining these elements in position in the closure. The removable section 14 of the cap is joined to the remainder of the cap, preferably at only two diametrically opposite zones [5, which" may be readily severed to remove the center'section from the closure. This center section preferably includes an embossed identification 15 which will serve to identify the type of solu'tiori' within the container. Also preferably there is an embossed ring I! on thecenter section which is normally pressed down as indicated against the foil diaphragm l0 and rubber disc 9 to provide a secondary seal for the container. V

The removable center section is preferably also provided with one or more protruding corners or points forming knife edges l 8.

In use the closure of the present invention is well adapted to retain the contents sterile and to maintain a sterile area at the top of the stopper. When it is desired to utilize the contents the removable center section is readily removed by severing the same'along the area [5. Until removed the center section identifies the solution and also serves as an indication of whether the contents have been tampered with. On removal of the center section the'same-ma'y be then used to engage its knife edges [8 with the foil'diaphragm close to the annular ring I3 so the center portion of the foil diaphragm may be readily cut and removed from the closure. On the removal of the foil diaphragm the exposedsurfaces are sterile. The removal of the foil diaphragm permits ready removal of the rubber disc 9, which may then be lifted Without eifort.

The closure of the present invention has advantages over those now in common use, such as that it requires no cap to be removed; the rubber disc is not required to extend under an inner cap from which it must be pulled, and only a single capis required to provide the desired closure.

In Figures 3 and 4 of the drawings Ihave indicated a form of the closure of the present invention for use where the stopper-is of the closed hole type. The form of the closure embodied in Figures 3 and 4 differs from that of Figures 1 and 2 substantially only in, first, the use of the closed hole stopper 20 in place of the open hole stopper'4 of Figures 1 and 2, and the omission of the rubber disc 9', which is not necessary Where a closed hole stopper is employed. The cap H-is identical in form to that of Figures land 2- including the same center removable'section |4.- The foil diaphragm H! in the form shown in Figures 3 and. 4. may be identical with that shown iii-Figures l and 2.

While the particular formsof the? closures herein' described are well adapted to' carry out the objects of the present invention, various modifications may be made and this invention is of the scope set forthin the appended claims.

I claim:

1. A closure for the neck of a-- container de= signed to hold a solution undervacuum, this-closure comprising, a plug fitting said neck and having a rim; a diaphragm covering the'out'er' surface of said plug and having its outeredge turned down over the rim of said plug, said diaphragm being formed of'a metal foil rendered moistureproof by an adherent film of plastic laminated thereto, and a metal cap having a removable cen-- tral section contacting said diaphragm and having a clamping ring engaging said neck and the periphery of said diaphragm.

2. A closure for the neck of a container designed to hold a solution under vacuum, this closure comprising, a plug'fitting said neck and having a rim, a diaphragm covering the outer surface of said plug and having its outer edge turned down over the rim of said plug, said diaphragm being formed of a metal foil rendered moisture-proof by an adherent film of plastic laminated thereto, and a metal cap having a removable central section contacting said diaphragm and having a clamping ring engaging said neck and the-periphery of said diaphragm, said removable central section having an embossed identification thereon.

3. A closure for the neck of a container designed to hold a" solution" under vacuum; this closure comprising, a-plug fittingsaid neck and having a rim, a diaphragm covering the outersurface of said plug and having'its outer edge turned down over the rim of said plug, said diaphragm being formed of a metal foil rendered moistureproof by an adherent film of plastic laminated thereto; and a metal cap having a removable central section contacting said diaphragm and having a clamping'rin'g engaging said neck and the periphery of said diaphragm, said removable central section having an'embossed ring for stiff ening the centralsectio'n.

4. A closure for the neck of a container designed to hold a solution under vacuum, this closure comprising, a plug fitting said neck and havinga a diaphragm covering the outer surface of said plug a'ndhaving its outer edge turned down over'the rim of said plug, said diaphragm being formed of a metal foilrend'ere'd moisture-proof by an adherent film of plastic laminated'the'reto, and ametal cap having a removable central section contacting said diaphragm andhaving a clamping ring engaging said neck and the periphery of said diaphragm, said removable central'secti'on having a protruding corner adjacent an edge adapted for cutting the said diaphragm on removal of said central section.

5. A closure for" a vacuum container having a neck, which closure comprises, a plug inserted in." saidneck, a diaphragm contacting the upper surface ofi'said plug for maintaining" a sterile area on said upper surface, said diaphragm extending over: the edge of said plug and being formed of a metal foil rendered fluid-tight by a layer of plastic material, and a metal cap including a clamping ringengaging the" neck of the bottle and said diaphragm for retaining said plug in said-neck and. providing an annular seal, said cap also including a removablef' central section contacting said diaphragm, which'central section may be removed while leaving said cap clamping said diaphragm and plug in position.

6'. A closure fora vacuum'container having a neck, which closure comprises, a plug inserted in said neck, a diaphragm contacting" the upper surfaceof said plug f'or'rnaintaining a sterile area on said upper surface; saiddiaphragm extending over the edge of said plug and being formed of a; metal foil rendered-fluid-tight by a layer of plastic material and ai' metal cap including a clamping ring; engaging theneck ofthe bottle and said diaphragm for retaining saidplug in said neck and providing. an annular seal,- said cap also including a removable central section contacting said diaphragm, which central section may be removed while leaving said cap clamping said diaphragm and plug in position, the center of said diaphragm being adapted to be cut away from the periphery of the diaphragm clamping said cap and exposing a sterile area on the upper surface of said plug.

7. A closure for a vacuum container having a neck, which closure comprises, a plug inserted in said neck, a diaphragm contacting the upper surface of said plug for maintaining a sterile area on said upper surface, said diaphragm extending over the edge of said plug and being formed of a metal foil rendered fluid-tight by a layer of plastic material, and a metal cap including a clamping ring engaging the neck of the bottle and diaphragm for retaining said plug in said neck and providing an annular seal, said cap also including a removable central section contacting said diaphragm, which central section may be removed while leaving said cap clamping said diaphragm and plug in position, the center of said diaphragm being adapted to be cut away from the periphery of the diaphragm clamping said cap and exposing a sterile area on the upper surface of said plug, the central section of said cap having embossed identification thereon and a stiffening ring.

8. A closure for a vacuum container having a neck, which closure comprises, a plug inserted in said neck, a diaphragm contacting the upper surface of said plug for maintaining a sterile area on said upper surface, said diaphragm extending over the edge of said plug and being formed of a metal foil rendered fluid-tight by' a layer of plastic material, and a metal cap including a clamping ring engaging the neck of the bottle and diaphragm for retaining said plug in said neck and providing an annular seal, said cap also including a removable central section contacting said diaphragm, which central section may be removed while leaving said cap clamping said diaphragm and plug in position, the center of said diaphragm being adapted to be cut away from the periphery of the diaphragm clamping said cap and exposing a sterile area on the upper surface of said plug, the central section of said cap having embossed identification thereon and stiffening ring, said central section being provided with a protruding corner adjacent an edge adapted for cutting said diaphragm.

9. A closure for a :vacuum container having a neck which closure comprises, a plug inserted in said neck and having open holes, a flexible rubber disk contacting the upper surface of said plug and terminating short of the rim thereof, a diaphragm over said disk and extending over the edge of the disk outwards and turned down over the rim of said plug, said diaphragm being formed of a metal foil being rendered fluid-tight by an adherent plastic material, and a metal cap including a clamping ring engaging the neck of the bottle and said diaphragm for retaining said plug in said neck, and providing an annular seal, said cap including a central section contacting said diaphragm, which central section may be removed While leaving such cap clamping said diaphragm and plug in position.

10. A closure for a vacuum container having a neck which closure comprises, a plug inserted in said neck and having open holes, a flexible rubber disk contacting the upper surface of said plug and terminating short of the rim thereof, a diaphragm over said disk and extending over the edge of the disk outwards and turned down over the rim of said plug, said diaphragm being formed of a metal foil being rendered fluidtight by an adherent plastic material, and a metal cap including a clamping ring engaging the neck of the bottle and said diaphragm for retaining said plug in said neck, and providing an annular seal, said cap including a central section contacting said diaphragm, which central section may be removed while leaving such cap clamping said diaphragm and plug in position, said central section being provided with a protruding corner adjacent the edge adapted for cutting said diaphragm.

RODNEY B. PUTZ.

References Cited in the file of this patent UNITED STATES PATENTS Number Name Date 359,412 Sugg Mar. 15, 1887 1,242,604 Schmitt Oct. 9, 1917 2,020,828 Goldberg Nov. 12, 1935 2,101,182 Kittredge et al. Dec. '7, 1937 2,156,987 Hill May 22, 1939 2,222,371 Nesset Nov. 19, 1940 2,231,418 Trotter Feb. 11, 1941 2,387,955 Ti'lson Oct. 30, 1945 2,465,269 Rohde et a1. Mar. 22, 1949 2,562,445 Butler et a1. July 31, 1951 OTHER REFERENCES Baxters General Price List No. 41, page 6. 

